A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Inclusion Criteria

• At least 18 years of age
• Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase).
• Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases).
• Minimum 3 lesions enrollment.
• Injectable disease (i.e., suitable for direct intratumoral injection based on the dose level volume of each cohort and cumulative lesion size; according to the investigator's judgement).
• A lesion amenable for additional tumor biopsy.
• Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
• Life expectancy more than 3 months.
• Willingness to provide mandatory tumor biopsy.
• Male and female patients who agree to use effective contraceptive methods.
• Signed informed consent.

Exclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance score >1.
• Significant and uncontrolled concomitant illness that would adversely affect the patient's participation in the study.
• Any prior organ transplantation.
• History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected basal or squamous-cell skin cancer or carcinoma, in situ of cervix or other local tumors considered cured by local treatment.
• History of unresolved viral hepatitis; systemic immune suppression including acquired immunodeficiency syndrome (AIDS) related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
• Prior splenectomy.
• New and progressive brain lesions.
• Poor bone marrow reserve resulting in low blood cell count.
• Poor liver and kidney functions, abnormal coagulation tests.
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
• Maintenance therapy with prednisolone >7.5 mg/day orally or equivalent during the study.
• Non-resolution of any prior treatment related toxicity to Grade <2, except alopecia, vitiligo, fatigue and hypothyroidism controlled with replacement therapies.
• Moderate to severe immune related adverse event to prior immune-modulating agents within 90 days prior to the first study treatment.
• Central nervous system lymphoma.
• Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients with lymphoma.
• Autologous HSCT less than 90 days prior to initiation of study intervention. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.